Ileostomy Infusion for Ileostomy

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of California, San Diego

Disqualifiers: Unable to consent, stoma infusion

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to prepare the intestines for surgery to reverse an ileostomy, where part of the intestine is diverted to an external bag. The approach involves returning the contents from the ostomy bag into the intestine before surgery to help the intestines adjust and function normally more quickly after the operation. Individuals with a diverting loop ileostomy planning for reversal might be suitable candidates. Participants will either receive the ileostomy infusion treatment or join a control group with no intervention. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this ileostomy infusion is safe?

Research has shown that the safety of ileostomy infusion remains under investigation. This treatment involves returning the contents of an ostomy bag to the intestine before surgery. Unfortunately, specific information on its safety for individuals is limited.

The trial is in an early stage, so researchers primarily focus on assessing its safety. During this phase, they closely monitor for any side effects or problems. Major safety issues would prevent the treatment from advancing beyond this stage.

Prospective participants should know that early trials like this are carefully monitored. Researchers closely observe participants to manage any side effects promptly. Consulting a doctor is crucial to understand the risks and benefits before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ileostomy infusion technique because it offers a new approach to managing patients with an ileostomy before a takedown operation. Unlike traditional methods that don't involve direct intervention, this technique involves infusing the ileostomy to potentially improve outcomes and prepare the site more effectively. This infusion approach could lead to better healing and fewer complications post-surgery, which would be a significant advancement over current practices.

What evidence suggests that ileostomy infusion is effective for retraining the intestine before takedown surgery?

Research has shown that returning the contents from an ostomy bag into the intestine might help prepare the intestine for surgery to reverse the ostomy. This method allows the intestine to "practice" handling waste again, which is beneficial because the intestine might struggle to function properly after prolonged inactivity. In this trial, participants will either receive the ileostomy infusion or join a control group with no intervention. A study comparing early and late ileostomy closures found that earlier closure led to shorter surgeries and less bleeding. This suggests that starting this process sooner could be advantageous. While researchers continue to study the infusion method, the aim is to make recovery after the reversal surgery smoother and faster. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for individuals with a temporary loop ileostomy who are preparing for an operation to reverse the ostomy. Participants must be able to infuse contents from their ostomy bag back into their intestine and give consent.

Inclusion Criteria

I have a temporary loop ileostomy and am being evaluated for its removal.

Exclusion Criteria

I cannot perform stoma infusion by myself.

I am unable to give consent by myself.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Intestinal Training

Participants undergo infusion of contents from the ostomy bag back into the intestine to re-train them prior to the ostomy takedown operation

2 weeks

Regular visits for infusion training

Surgery and Immediate Recovery

Participants undergo the ostomy takedown operation and are monitored for the return of bowel function

1-5 days

Inpatient stay for surgery and recovery

Follow-up

Participants are monitored for complications and ease of stoma infusion post-surgery

30 days

Follow-up visits to assess recovery and complications

What Are the Treatments Tested in This Trial?

Interventions

• Ileostomy Infusion

Trial Overview The study tests whether infusing intestinal contents from an ostomy bag back into the intestine before surgery can re-train the bowel and help it recover normal function faster after the reversal operation.

How Is the Trial Designed?

Group I: Ileostomy infusion Active Control 1 Intervention

perform infusion if ileostomy prior to takedown operation

Group II: Control Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6238807/

Postoperative Outcomes of Stoma Takedown Perioperative outcomes are shown in Table 2. The time from stoma formation to takedown was 5.3 months. Most of the patients underwent an ileostomy rather than ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1015958423001550

Outcome of early versus late ileostomy closure in patients ... Patients undergoing early closure of the ileostomy had significantly shorter operation duration (p<0.001) and intraoperative bleeding (p<0.001) compared to late ...

3. oncotarget.com oncotarget.com/article/24077/text/

Meta-analysis of early versus late closure of a temporary ... A systematic review showed that closure of a temporary ileostomy was associated with low mortality (0.4%), but overall morbidity following a ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9123394/

Early vs. standard reversal ileostomy: a systematic review ... A systematic review of the current randomised controlled trial literature comparing early and standard ileostomy closure after rectal surgery was performed.

5. mdpi.com mdpi.com/2077-0383/12/2/452

Postoperative Morbidity Following Loop Ileostomy ... The overall morbidity rate after ileostomy closure is approximately 20% [9,22], and small bowel obstruction is the most common complication [23, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11415412/

Management of complications in patients with an ileostomy Using sensor-based smart wearables and information technology, patients can better manage and control the ostomy and reduce its complications.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33280399/

Protocol-Based Intravenous Fluid Hydration for Newly ... Standardized, mandatory at-home intravenous hydration following ileostomy creation leads to a significant reduction in postoperative incidence of dehydration.

8. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/codi.15566

Risk factors for readmission with dehydration after ... The primary outcome was the pooled risk ratio of clinically relevant variables potentially associated with dehydration-related readmission ...

9. perioperativemedicinejournal.biomedcentral.com perioperativemedicinejournal.biomedcentral.com/articles/10.1186/s13741-021-00226-z

Risk factors and outcomes associated with postoperative ileus ... Postoperative ileus (POI) is associated with increased patient discomfort, length of stay (LOS), and healthcare cost.

10. clinicaltrials.gov clinicaltrials.gov/study/NCT04669964

NCT04669964 | Evaluating Ileostomy Hydration Protocol This is a prospective observational study on patients who undergo an ileostomy creation after implementing a hydration algorithm as routine care at Robert ...